放化疗对比经口激光显微手术治疗早期T分期（cT1-T2）下咽癌：一项前瞻性随机初步研究
Chemoradiotherapy versus transoral laser microsurgery for early T-stage (cT1-T2) hypopharyngeal cancer: A prospective randomized pilot study.
文献信息
| PMID | 42710434 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Ciou Nan Ye |
| 作者单位 | Department of Otolaryngology, Head and Neck Surgery, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan; Department of Otolaryngology, Head and Neck Surgery, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan. |
| 期刊 | American journal of otolaryngology |
| SCI 分区 | Q2 |
| IF | 1.8 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 早期T分期（cT1-T2）下咽鳞状细胞癌（HSCC）在肿瘤控制与功能保留之间的平衡方面构成治疗挑战。
目的： 比较基于经口激光显微手术（TLM）的治疗路径与根治性放疗为基础（放疗伴或不伴同步化疗，RT/CCRT）的治疗路径在早期T分期HSCC中的肿瘤学和功能结局。
设计、场所和参与者： 这项前瞻性随机初步研究于2016年至2021年在一家三级医疗中心进行。共纳入17例未经治疗的cT1-T2 HSCC患者。
干预： 参与者被随机分配接受基于TLM的路径（n = 9）或根治性RT/CCRT（n = 8）。
主要结局： 主要终点为末次随访时的功能性喉保留率（最短随访时间：1年）。
关键结果： 在TLM组中，55.6%（5/9）的患者因不良病理特征需要辅助CCRT。RT/CCRT组的1年功能性喉保留率显著高于TLM组（100% vs. 44.4%；Cramer's V = 0.61；95% CI，0.39-0.88；P = 0.029）。在嗓音质量方面，RT/CCRT显示出有利结局，基频微扰较低（0.76% vs. 1.68%；效应量，0.49；95% CI，-0.02至0.76；P = 0.046）。在无病生存方面观察到有利于RT/CCRT组的潜在趋势（风险比，0.26；95% CI，0.03-2.30；P = 0.189）。
危害： 两组均未报告4级或以上治疗相关不良事件（CTCAE v5.0）。然而，在TLM组中观察到下咽纤维化伴狭窄发生率较高的潜在趋势（Cramer's V = 0.52；P = 0.082）。
结论： 对于早期T分期（cT1-T2）HSCC，根治性RT/CCRT在喉保留和声学质量方面提示可能优于基于TLM的路径，可能是通过避免病理淋巴结阳性或高危疾病中三联治疗的累积并发症。虽然肿瘤控制似乎相当，但鉴于初步队列有限，这些发现仍具有假设生成性质，需要在更大规模的多中心试验中验证。
试验注册： 未前瞻性注册（初步试验经台中慈济医院IRB批准，REC105-07）。
英文摘要
BACKGROUND: Early T-stage (cT1-T2) hypopharyngeal squamous cell carcinoma (HSCC) presents a therapeutic challenge in balancing oncological control with functional preservation.
OBJECTIVES: To compare the oncological and functional outcomes between transoral laser microsurgery (TLM)-based treatment pathway and definitive radiation-based (radiotherapy with or without concurrent chemotherapy, RT/CCRT) treatment pathway for early T-stage HSCC.
DESIGN, SETTING, AND PARTICIPANTS: This prospective randomized pilot study was conducted at a tertiary care hospital from 2016 to 2021. Seventeen treatment-naïve patients with cT1-T2 HSCC were included.
INTERVENTIONS: Participants were randomized to undergo either TLM-based pathway (n = 9) or definitive RT/CCRT (n = 8).
PRIMARY OUTCOMES: The primary endpoint was the functional laryngeal preservation rate at last follow-up (minimum follow-up: 1 year).
KEY RESULTS: In the TLM group, 55.6% (5/9) of patients required adjuvant CCRT due to adverse pathological features. The 1-year functional laryngeal preservation rate was significantly higher in the RT/CCRT group than in the TLM group (100% vs. 44.4%; Cramer's V = 0.61; 95% CI, 0.39-0.88; P = 0.029). Regarding voice quality, RT/CCRT demonstrated favorable outcomes with lower jitter (0.76% vs. 1.68%; effect size, 0.49; 95% CI, -0.02 to 0.76; P = 0.046). A potential trend favoring the RT/CCRT group was observed for disease-free survival (Hazard Ratio, 0.26; 95% CI, 0.03-2.30; P = 0.189).
HARMS: No grade 4 or higher treatment-related adverse events (CTCAE v5.0) were reported in either arm. However, a potential trend toward a higher incidence of hypopharyngeal fibrosis with narrowing was observed in the TLM group (Cramer's V = 0.52; P = 0.082).
CONCLUSION: For early T-stage (cT1-T2) HSCC, definitive RT/CCRT suggested potential functional advantages in laryngeal preservation and acoustic quality over a TLM-based pathway, likely by avoiding the cumulative morbidity of trimodality therapy in pathologically node-positive or high-risk disease. While oncological control appeared comparable, these findings remain hypothesis-generating given the limited pilot cohort, warranting validation in larger multicenter trials.
TRIAL REGISTRATION: Not prospectively registered (Pilot trial approved by IRB of Taichung Tzu Chi Hospital, REC105-07).